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EC number: 244-168-5
CAS number: 21041-95-2
A skin sensitisation study was performed in the guinea pig according to the Guinea Pig Maximisation Test (also known as Magnusson and Kligman) method to evaluate the sensitisation potential of test item Cadmium hydroxide. Parameters monitored during this study included mortality, body weight measurement and local and clinical observations.
The experiment was conducted in compliance with requirements of the OECD No. 406 (1992); Commission Regulation (EC) No 440/2008 of 30 May 2008, B.6 and EPA OPPTS 870.2600 (2003).
Ten test animals were subjected to sensitisation procedures in a two-stage process, induction phase, consisting in an intradermal treatment (three pairs of injections (0.1 mL/site) with and without Freund's Complete Adjuvant (FCA) formulation) and a topical application (0.5 mL for 48 (± 2) hours exposure) (dermal treatment under an occlusive dressing). The test item was used at 1% (w/v) test item formulated in 1% Methyl Cellulose (1% MC) and 1% (w/v) formulated in FCA:Saline (1:1) for intradermal injections and at a concentration of 75% (w/v) test item in 1% MC for topical sensitisation treatment. Five control guinea pigs were simultaneously exposed to 2 injections of FCA and saline in a 1:1 (v/v) mixture, 2 injections of 1% MC and 2 injections of 1% MC formulated in a 1:1 mixture (v/v) of FCA and saline during the sensitisation phase. Since erythema was observed in the preliminary tests (intradermal induction), application of 0.5 ml of 10% sodium dodecyl sulphate (SDS) is not needed prior to topical induction.
Two weeks after the last induction exposure, a challenge dose at a concentration of 75% (w/v) test item in 1% MC was administered on the left side of all animals. The right side of the animals was treated with 37.5% (w/v) test item in 1% MC on the right side (50% of the maximum challenge concentration (safeguard dose)). Challenge was performed by dermal application of the test item for 24 (± 2) hours with a fully occlusive foil (Closed Patch Test).
Animals were assessed for any notable systemic clinical signs once daily and skin reactions were observed and recorded at the following time-points:
There was no mortality related to the administration of the test item. There was no effect on body weight in any animals.
In conclusion, under the conditions of the present assay the test item Cadmium hydroxide was shown to have no sensitisation potential and is classified as a non-sensitiser, according to current GHS criteria.
The study result triggers the following classification/labelling:
- GHS (rev. 8) 2019: Not classified
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